Clene Stock Jumps After FDA Opens Door To Accelerated Approval For ALS Drug

by | May 4, 2026 | General

Clene Inc. (NASDAQ:CLNN) shares are up 6.68% on Monday as the company is filing for accelerated approval of its ALS treatment following a constructive meeting with the FDA.

Amyotrophic Lateral Sclerosis (ALS), or Lou Gehrig’s disease, is a neurodegenerative disease that destroys motor neurons in the brain and spinal cord, causing voluntary muscle loss, paralysis, and respiratory failure.

Clene (CLNN) Seeks Accelerated FDA Approval For ALS Drug

Clene recently announced that the FDA has agreed to review its New Drug Application (NDA) submission for CNM-Au8, a treatment for amyotrophic lateral sclerosis (ALS).

The company plans to submit the NDA in the third quarter of 2026.

The U.S. Food and Drug Administration (FDA) stated that the “proposed data may be capable of supporting the submission and review of an [NDA] under the accelerated approval pathway” for CNM-Au8 based on neurofilament light (NfL) biomarker data.

The FDA acknowledged NfL could potentially serve as a reasonably likely surrogate endpoint.

“We are committed to working with the Agency on this filing and are conducting the Phase 3 confirmatory study for CNM-Au8, which we intend to commence in the first quarter of 2027,” said Rob Etherington, president and CEO of Clene.


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CLNN Technical Analysis: Trend, Momentum And Key Levels

Clene is currently trading within a strong upward trend, positioned 11.2% above its 20-day simple moving average (SMA) and 21% above its 50-day SMA, suggesting robust short-term momentum. The stock is also trading 24.6% above its 100-day SMA, indicating a solid intermediate trend.

The relative strength index (RSI) sits at 53.46, reflecting a neutral momentum state, which suggests that the stock is neither overbought nor oversold at this time.

Meanwhile, the moving average convergence divergence (MACD) is below the signal line, indicating a bearish trend, which could suggest caution for traders.

  • Key Resistance: $7.00 — A critical level where upward momentum may stall.
  • Key Support: $6.00 — A level that could provide buying interest if tested.

Clene has shown a remarkable 12-month performance of 137.46%, indicating strong long-term growth and investor interest. Currently, the stock is trading well above its 52-week low of $2.28, reflecting a significant recovery and positive sentiment in the market.

CLNN Stock Price Activity: Clene shares were up 6.68% at $6.55 at the time of publication on Monday, according to Benzinga Pro data.

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